Principal Biostatistician - Exploratory Data Analysis

The Principal Biostatistician assumes responsibility for methodological and statistical aspects of a project or group of clinical studies, with general direction from Therapeutic Area lead biostatistician. Provide leadership and mentorship on statistical matters to interdepartmental clinical / regulatory teams. In some cases incumbent could serve as specialist in a particular statistical area or application.

In this role a typical day may include the following:

• Work with the clinical and regulatory functions to define study endpoints and perform relevant sample size calculations. Develop statistical analysis plan (SAP)
• With mentorship from senior departmental staff, assume leadership role for providing statistical support to one or more study teams on all statistical matters. Act as direct liaison to the study team.
• Own the definition and documentation of derived variables needed to produce planned TFL. Assume responsibility for accuracy of derived variables. Expertise and some practical experience in use of advanced statistical methodologies, especially with application to clinical trial design and analysis
• Lead all aspects of execution of the statistical analysis according to the SAP and preparation of the statistical methods and results sections for the clinical study report (CSR). Provide support for the study team to move CSR through the review and approval process. Provide statistical insight into interpretation and discussion of study results
• Produce / coordinate production of statistical summaries, analyses, reports, and materials for submission to regulatory authorities or to independent monitoring committees. Review submission documents, such as IND, BLA, or CTD to insure statistical validity and accuracy response to Health Authorities from countries
• Collaborate with project team on the production of the clinical development plan (CDP).
• Work with senior departmental staff to develop statistical position on studies or project issues acting as a representative to extended project team.
• Provide input to Therapeutic Area lead biostatistician on project activity and timeline tracking, resource planning, and preparation of scientific reports or position papers.

This role might be for you if:

• PhD + 0 year experience or MS + 6 yrs biotech / pharma experience in statistics or area with 6 to 8+ years of experience in different phases of a trial
• Knowledge of pharmaceutical / biotech clinical development with the ability to use statistical methods to assess/improve efficiency and effectiveness in drug development
• Expertise with experience in using advanced statistical methodologies, applicable to clinical trial design and analysis
• Working knowledge of regulatory guidelines for drug development, NDA submissions, and statistical practices, e.g., CTD guidance, ICH guidelines
• Support NDA/sDNA submission and respond to FDA queries. EMA type II submission experience and in respond to Health Authorities from other countries
• Basic understanding of key clinical and regulatory concepts, endpoints, and trial designs in multiple therapeutic areas / indications
• Familiarity and practical experience in design, production, and use of submission-quality electronic datasets.
• Ability to define and meet study / project timelines for deliverables such as protocol, clinical study summaries, and key analyses
• Strong interpersonal skills, experience leading internal teams, extensive leadership skills and extensive outsourcing project managing experience with CROs.
• Ability to coordinate, lead, and empower teams.
• Proficiency with SAS, S-Plus/R, Sample size calculation software (e.g., EAST and Nquery)

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.